Annexure-1

GMP CHECKLIST

(Based on WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients stated as per
Annex 2- WHO Technical report Series(TRS), No. 957, 2010; Good Manufacturing Practice guide for
Active Pharmaceutical Ingredients ICH Harmonised Triplicate Guideline stated as per ICH Q9; and GMP
requirements as per Directives No. 2001/83/EC latest amended vide Directive 2011/62/EU)

1 Location and surroundings: Self appraisal to Observations to Remarks

be filled by the be noted by the
manufacturer inspecting team
along with all at the time of
details (yes or no inspection
type reply will not
be acceptable)
1.1 How factory building is situated and
controlled to avoid risk of
contamination from external
environment including open sewage,
drain, public lavatory or any other
factory which produces disagreeable
or obnoxious, odors, fumes,
excessive soot, dust, and smoke,
chemical or biological emissions.
Pls specify industries /
establishments adjoining
manufacturing site.

2 Building and premises: -

2.1 How the building has been designed

 constructed and maintained to suit
the manufacturing operations so as
to produce drugs under hygienic
conditions.
Pls specify nature of construction
used in the facility in respect of its
maintenance and hygienic
conditions.

2.2 Whether the building confirm to the

conditions laid down in the Factories
Act, 1948
Pls attach valid factory certificate/
license issued by the competent
authority.

2.3 Specify how the premises used for

manufacturing operations and
testing purpose prevents
contaminations and cross
contamination is:
a) Compatible with other drug
manufacturing operations that may
be carried out in the same or
adjacent area.
Pls specify any special criteria for

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SOP No.: EP-INS-004 1
 the product manufacturered. e.g.
temperature, humidity, air class
requirements maintained for aseptic
products, etc.

2.4 b) Whether adequate working space

is provided to allow orderly and
logical placement of equipment,
materials and movement of
personnel so as to avoid risk of mix-
up between different categories of
drugs and to avoid possibility of the
contamination by suitable
mechanism.

Pls specify space left around the

machines. Pls attach equipment lay
out, men and material movement,
waste movement if applicable.

2.5 c) Describe the pest, insects, birds

and rodents control system
followed in the premises.

Attach copy of pest / rodent

control schedule along with
contract agreement if any.

2.6 d) What measures have been taken

to make Interior surface of (walls,
floors, and ceilings) smooth and free
from cracks, and to permit easy
cleaning

Specify material of construction and

finish for walls, ceiling, floor, coving
etc. i.e. whether Epoxy or PU
coated, kota / granite stone with
epoxy sealed joints, solid / GI /
gypsum / cal. Silicate board ceiling
with epoxy, PU or any other pre-
fabricated panel (GRP, powder
coated SS or Aluminum etc.) paint.

2.7 e) What measures have been taken

so that the production and
dispensing areas are well lighted and
effectively ventilated, with air
control facilities.
 Pls specify the lux level maintained
in various parts of the premise.

2.8 Pls specify the air handling system

used in various areas like stores,
production, packing, QC areas etc.

SOP No.: EP-INS-004 Page

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 2.9 f) Specify drainage system
which prevents back flow and
entry of insects and rodents into
the premises. Drains should be
of adequate size and should be
provided with an air break or a
suitable device to prevent back-
siphonage

(pls specify number and location

of drains installed)

2.10 Containment area:

Any production activities (including

weighing, milling or packaging) of
highly toxic non-pharmaceutical
materials such as herbicides and
pesticides should not be conducted
using the buildings and/or
equipment being used for the
production of APIs. Handling and
storage of these highly toxic non-
pharmaceutical materials should be
separate from APIs.

3 Water system: -

3.1 Whether the unit has validated

system for treatment of water drawn
from own or any other source to
render it potable in accordance with
standards specified by BIS or local
municipal norms.

Pls specify source of raw water

and give details of treatment
processes, sampling points,
distribution and storage system for
raw and purified water.

3.2 How bio burden in purified water

controlled / reduced.

3.3 How water tank are cleaned

periodically and records maintained
thereof. How water distribution
system is sanitized to control
microbial contaminations.

4 Disposal of waste: -
 4.1 Specify the system of disposal of
sewage, and effluents (solid, liquid,
and gas) from the manufacturing
site.

(Enclosed the copy of NOC

obtained from State Pollution
Control Board in this regard).

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 4.2 Whether provision for disposal of
bio-medical waste made as per the
provisions of the Bio Medical Waste
(Management and Handling) Rules
1996.

5 Warehousing Area: -

5.1 Whether adequate areas have been

allocated for warehousing of Raw
Materials, intermediates, Packaging
Material, products in quarantine,
finish products, rejected or returned
products.

How these areas marked

or segregated.

Please specify the total area

provided for warehousing.

5.2 How the warehousing areas being

maintained to have good storage
conditions. Are they clean and dry
and maintained within acceptable
temperature limits?

5.3 Specify the storage arrangement

provided for materials which
sensitive to temperature, humidity
and light and how the parameters are
monitored.

Is cold room or deep freezers required

for storage of goods? If yes, how the
temperature is monitored.

5.4 Whether proper racks, bins and

platforms have been provided for
the storage.

5.5 Whether receiving and dispatch bays

are maintained to protect in coming
and out going materials.

5.6 How incoming materials are treated

and cleaned before entry into the
plant.
 Please specify the cleaning system
for the outer surface of the
container.

5.7 How quarantined materials are

segregated from other materials.
How access to quarantined area is
restricted.

5.8 Whether separate sampling area for

active Raw Materials and Excipients
is provided and maintained.

If yes, what is the control on entry of

material and men into the sampling
area. Whether reverse LAF have

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 been provided for sampling.
Whether log book for
sampling booth maintained.

If not what provision has been

made for sampling so as to prevent
contamination, cross contamination
and mix-ups at a time of sampling.

5.9 Specify the arrangements provided

to sample the primary packaging
materials foils, bottles, etc which
are used as such.

5.10 Pls specify sampling plan used.

Which type of sampling tools are
used and how they are cleaned,
dried and maintained.

5.11 How containers are cleaned

before and after sampling. Who
carries out the sampling?

(Pls specify whether the sampling is

carried out as per the current SOP).

5.12 What precautions are taken

during sampling of photosensitive,
hygroscopic materials?

5.13 What provisions have been

made for segregated storage of
rejected, recalled or returned
materials or products.

How is the access to these areas

restricted.

5.14 How highly hazardous,

poisonous and explosive materials,
narcotics, and psychotropic drugs
are handled and stored.

How these areas are safe and secure.

Is there certification from competent
authority for handling of explosives
 etc. If any. Pls attach the certificate
issued by the competent authority.

5.15 How printed secondary

packaging materials are stored in
safe, separate and secure manner.

5.16 Specify the arrangement

provided for dispensing of starting
materials. What is the control on
entry of material and men into the
dispensing area? Whether reverse
LAF have been provided for
dispensing with back ground clean
air supply. Whether pressure
differential is maintained between
the dispensing and adjacent areas.

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